Brief Title
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer
Official Title
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a Multicenter Prospective Randomized Study
Brief Summary
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a
multicenter prospective randomized study
Detailed Description
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer
Study Type
Interventional
Primary Outcome
Detection rate
Secondary Outcome
Detection rate
Condition
Endometrial Cancer
Intervention
Hysteroscopic injection
Study Arms / Comparison Groups
cervical injection
Description: Fluorescent SLN Imaging With Indocyanine Green (ICG), using near-infrared fluorescence imaging, will be used as a dye for SLN mapping. Injections will be performed intraoperative. Concentration of ICG used is 1.25mg/mL, the 25mg dry powder bottle is mixed with 20 mL of sterile water in the operating room, and 4 mL is injected directly into the cervix. This solution was injected intracervically at 3 and 9 o'clock positions, both submucosally and deep into the cervical stroma. A spinal needle 18-gauce is used to inject the ICG. The 4 mL can be divided into 4 separate injections (1 mL each). The ICG should be injected slowly, at a rate of 5 to 10 seconds per quadrant.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
165
Start Date
March 20, 2017
Completion Date
February 25, 2020
Primary Completion Date
March 28, 2019
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent from the patient;
- Histological diagnosis of endometrial cancer (including type I and II EC);
- Early stage (FIGO stage < 4);
- Age older than 18 years.
Exclusion Criteria:
- Preoperative diagnosis of extra-uterine disease;
- Preoperative suspicious of gross positive nodes;
- Execution of neoadjuvant chemotherapy;
- Contraindication to upfront general anesthesia and or mini-invasive surgery;
- Systemic infections ongoing;
- Pregnancy ongoing.
Gender
Female
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Antonino Ditto, MD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT04302714
Organization ID
INT 09/17
Responsible Party
Sponsor
Study Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor
Antonino Ditto, MD, Principal Investigator, Fonsazione IRCCS Istituto Nazionale Tumori Milano
Verification Date
February 2020